中国循证医学杂志

中国循证医学杂志

促进临床试验数据共享,提高临床试验的透明化

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临床试验数据共享可增加临床试验的透明度,提高临床试验的真实性。现有的临床试验数据透明化要求并不完善,要达到临床试验数据共享常态化,目前尚面临着较多问题。本文分析了临床试验数据共享工作存在的各种问题,并在数据所有权、技术、操作和法律层面等方面提出了解决思考,呼吁临床试验数据共享,以促进临床试验透明化工作,最大限度地降低临床试验风险,使数据共享发挥最大效益。

Sharing clinical trial data can increase the transparency of clinical trials and improve the its authenticity. The current requirements of clinical research data transparency is not fully adequate, and it is still difficult to create an environment in which the sharing of the clinical trial data becomes the norm. The article analyzed various concerns on data sharing and proposed solutions in data ownership, technology, implementation, and legal issues systematically, calling for clinical trial data sharing in order to promote transparency of clinical trials, and looking forward to minimize the risks and maximize the benefits of data sharing.

关键词: 临床试验; 数据共享; 透明化; 临床试验真实性

Key words: Clinical trial; Data sharing; Transparency; Authenticity of clinical trial

引用本文: 林伟青, 田然, 赵晨, 商洪才, 吴泰相, 李幼平, 卞兆祥. 促进临床试验数据共享,提高临床试验的透明化. 中国循证医学杂志, 2018, 18(9): 893-895. doi: 10.7507/1672-2531.201801065 复制

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